[E-Daily Reporter NA EUN-KYUNG ] Genomictree Inc.(228760)is set to enter a phase of full-scale revenue generation following the approval of a deferral for the evaluation of its new medical technology, the bladder cancer molecular diagnostic test “EarlyTect-B.” This is because, following product approval from the Ministry of Food and Drug Safety and European CE-IVDR certification last January, the company also secured approval for a deferral of the New Medical Technology Assessment this month, making it possible for domestic medical institutions to prescribe the test as a non-insured service starting this August. As the company has already established a nationwide testing infrastructure, it plans to fully implement its commercialization roadmap, starting with domestic sales in the second half of the year and leading to future inclusion in the national health insurance coverage.

Non-Insured Prescriptions to Begin in August… Domestic Sales to Gain Momentum

According to industry sources on the 15th, EarlyTec-B has obtained approval for a deferral of the New Medical Technology Evaluation, making it possible for domestic medical institutions to prescribe the device on a

non-insured

basis starting this August. The New Medical Technology Evaluation Deferral System allows innovative medical technologies that meet certain requirements to be used in clinical settings on a non-reimbursed basis for up to two years until the evaluation is completed. Following the news, Genomictree Inc.’s stock closed at 12,480 won on the 14th—up 13.45% from the previous trading day—and rose as high as 13,200 won during intraday trading.

Genomictree Inc. has been successfully clearing key milestones toward commercialization one by one. Last January, it obtained a Class 3 manufacturing license for in vitro diagnostic medical devices from the Ministry of Food and Drug Safety (MFDS) and completed certification under the European In Vitro Diagnostic Medical Devices Regulation (CE-IVDR). With the addition of this approval for the New Medical Technology Evaluation Deferral System, the company has now entered the stage where actual prescriptions and sales will begin.

The company has also largely completed preparations to expand initial sales. In collaboration with South Korea’s largest contract testing laboratory, it has established a system capable of providing testing services to approximately 4,000 medical institutions nationwide. The company explains that by securing a nationwide infrastructure—covering everything from specimen collection to test execution and result reporting—it can offer consistent testing services anywhere in the country from the very start of the launch.

Market expansion strategies will also be implemented in phases. First, starting in August, the company plans to expand non-covered prescriptions at primary care facilities, focusing on urology and internal medicine departments. In the fourth quarter, it intends to expand the market to general hospitals once the registration of testing codes is complete. Subsequently, the company plans to extend the scope to include health screening programs, with sales at health screening centers expected to gain momentum starting next year.

Insurance coverage is another key growth driver. Genomictree Inc. aims to secure sales performance for non-insured services during the evaluation grace period, then proceed through the new medical technology evaluation and insurance listing procedures to achieve insurance-covered prescriptions at approximately 200 hospitals and perform over 1 million tests annually. If more than 1 million tests are performed on patients undergoing recurrence monitoring and those aged 50 or older with hematuria, the company estimates its maximum annual revenue could reach approximately 78 billion won.

The securities industry also views this year as the inaugural year for the commercialization of EarlyTec-B. While Genomictree Inc.’s revenue to date has been largely driven by the colorectal cancer test “EarlyTec-C,” analysts expect EarlyTec-B to emerge as a new growth engine starting in the second half of the year.

U.S. FDA Clinical Trials

to Begin

in the Second Half… Setting Sights on a 4 Trillion to 5 Trillion Won Market

After establishing a foothold in the domestic market, the company’s next key battleground is

the United States

. Genomictree Inc. plans to begin confirmatory clinical

trials in the second half of the year

for “EarlyTect BCD Plus,” an enhanced version of EarlyTect-B, to secure approval from the U.S. Food and Drug Administration (FDA). The company is currently engaged in sprint discussions with the FDA regarding the clinical trial design and has already secured Breakthrough Device designation and a CMS reimbursement rate of $192 (approximately 290,000 won).

The U.S. market has significantly greater growth potential than the domestic market. According to guidelines from the American Urological Association (AUA), the prevalence of microscopic hematuria is reported to range from approximately 2.4% to 31.1%, with the general average at around 6.5%. Applying this to the U.S. adult population, the number of patients with microscopic hematuria alone is estimated to be between 15 and 20 million. If patients with gross hematuria are included, the actual market for bladder cancer screening expands even further. Applying Genomictree Inc.’s test price of approximately $192, the total addressable market (TAM) in the U.S. is estimated to be between $3 billion and $4 billion (approximately 4 trillion to 5 trillion won).

This market potential is also evident from competitive examples. New Zealand-based Pacific Edge performs approximately 27,000 tests annually in the U.S. using only laboratory-developed tests (LDTs) without FDA approval, recording sales of approximately 16 billion won in 2023. Genomictree Inc. is pursuing a strategy of initially entering the market via LDTs and then obtaining FDA approval to expand insurance coverage and market access.

Genomictree Inc. official stated, “If we successfully complete clinical trials in the U.S. and obtain FDA approval, we will be able to secure much broader market access than with LDT and expand insurance coverage,” adding, “We believe business opportunities in the U.S. market will grow even further.”